1. Field of the Invention
Numerous markers have been suggested to assess the prognosis or monitor the continued presence of carcinomas in a mammalian host. As illustrative, for human breast carcinomas, calcitonin, carcinoembryonic antigen (CEA) and its related materials, ferritin, transferases and milk proteins have been suggested. None of them has found acceptance as a specific sensitive breast tumor marker to be used in clinical management of the disease.
There are many situations in the diagnosis and treatment of cancer in mammals where a reliable test having a low level of false negatives would be extremely valuable by itself and particularly in conjunction with other tests, such an imaging. Desirably, the test should be relatively simple and accurately and reliably measure the diagnostic marker in the range of interest.
2. Description of the Prior Art
Mammary tumor cell surface antigens have been identified in the sera of rats with mammary carcinomas. (Ghosh et al., (1979) J. Natl. Cancer Inst. 62:1229-1233). Some of these membrane fragments appear to be antigenic to the patient and may exist as free antigens or together with the corresponding specific antibodies as circulating, soluble immune complexes in circulation. Hoffken et al., (1977) Br. Med. J. 2:218-220); Kim et al., (1975) PNAS U.S.A. 72:1012-1016). The isolation and characterization of normal human mannary epithelial antigens prepared from human milk fat globules has been reported. Ceriani et al., (1979), In: Boelsma E., Rumke P. eds. Applied Methods in Oncology. Amsterdam: Elsevier, 101-116; Ceriani et al., (1977) PNAS U.S.A. 74:582-586; Ceriani et al., (1980) In: Mcgrath C. ed. Workshop Processings "Systematic of Breast Cell Transformation." New York: Academic Press, 3356 and Peterson et al., (1978) Int. J. Cancer 22:655-661. See also U.S. Pat. No. 3,979,507 and references described therein.